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Primary care physicians began prescribing antacid therapy for chronic cough
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The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid suppression) on bronchial hyper-responsiveness and whether there is a symptomatic improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omeprazole and ranitidine | Other | 20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | 20 mg BD tablet 8 weeks duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Methacholine Sensitivity | Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20). To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine | baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyn H Morice, Professor | Hull University Teaching Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital | Cottingham | East Yorkshire | HU16 5JQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11678780 | Background | Morice AH, Kastelik JA, Thompson R. Cough challenge in the assessment of cough reflex. Br J Clin Pharmacol. 2001 Oct;52(4):365-75. doi: 10.1046/j.0306-5251.2001.01475.x. No abstract available. |
| Label | URL |
|---|---|
| Publication Link | View source |
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Patients had to have a positive methacholine challenge, and reflux associated chronic cough
Patients recruited at the cough clinic at castleHill Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Antacid Therapy | Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Antacid Therapy | Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Methacholine Sensitivity | Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20). To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine | All subjects recruited with efficacy data recorded after week T0 will be included in the ITT population for analysis. Assuming a within subject standard deviation(for change in PC20) of no more than 2.71 units, 30 subjects are sufficient to provide 80% power to detect a treatment difference of 1.8 units using a 5% two sided significance test | Posted | Mean | Standard Deviation | mg/ml | baseline and 8 weeks |
|
8 week
data collected at each visit of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antacid Therapy | Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical trials Manager | Hull and East Yorkshire Hospitals Trust | 01482 624067 | c.e.wright@hull.ac.uk |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D011899 | Ranitidine |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Ranitidine | Drug | 300 mg od nocte tablet 8weeks duration |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire | Not Posted | 8 weeks | Participants |
| 0 |
| 3 |
| 0 |
| 3 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005663 | Furans |